IMPACT-AFib is a prospective, randomized, and open-label education intervention trial. Patients who, based on administrative and claims data, appear to have AFib and a CHA2DS2-VASc score of 2 or greater and not currently on oral anticoagulant (OAC) therapy will be randomized in a 1:1 fashion to usual care vs patient-level and provider-level educational interventions. The primary outcome is the proportion of patients started on oral anticoagulation over the course of a 12-month study period. Approximately 30,000 patients (randomized 1:1) will be enrolled across the United States. The follow-up time will be 12 months from the date of the randomization.
IMPACT-AFib is an initiative that seeks to understand the impact of education on select patients with atrial fibrillation (AFib) and their providers about the importance of anticoagulation medications for reducing the risk of stroke. IMPACT-AFib is a joint initiative between major healthcare plans, the U.S. Food and Drug Administration (FDA), the Duke Clinical Research Institute (DCRI) and the Harvard Pilgrim Health Care Institute.
Though multiple well-designed research studies have reached the same conclusion: OAC medications can decrease the risk of stroke in patients with AFib, OAC use has not increased.
The research hypothesis is that among patients with AFib with guideline indications for OAC stroke prevention who have not received any OAC dispensing for at least one year, an education intervention at the patient-level and the provider-level will increase the proportion of patients started on OAC for stroke prevention and, in turn, reduce the rate of stroke-related hospitalizations.